FDA 510(k) Application Details - K231645

Device Classification Name	More FDA Info for this Device
510(K) Number	K231645
Device Name	PherDal« At-Home Insemination Kit
Applicant	PherDal Fertility Science, Inc. 405 W 2nd St, Unit 1141 Dixon, IL 61021 US Other 510(k) Applications for this Company
Contact	Dr. Jennifer Hintzsche Westphal Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2023
Decision Date	12/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review